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Music Video for AYA-Parent Communication and Resilience


N/A
11 Years
24 Years
Open (Enrolling)
Both
Hematopoietic/Lymphoid Cancer, Psychosocial Effects of Cancer and Its Treatment, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Music Video for AYA-Parent Communication and Resilience


OBJECTIVES:

- Compare the efficacy of a Therapeutic Music Video (TMV) intervention with a Therapeutic
Music Video plus Parent (TMV+P) intervention on outcomes for adolescents/young adults
(AYA) undergoing treatment for high-risk cancer.

- Compare the efficacy of a TMV intervention with a TMV+P intervention on outcomes for
parents of AYA with high-risk cancer.

- Determine relationships of parent distress and parent perceived family environment with
AYA outcomes using a mixed methods approach. (exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to age in years
(11-13 vs 14-17 vs 18-24). Parents are randomized to 1 of 2 intervention arms.

- Arm I (TMV, low-dose parent): AYA patients undergo 60-minute sessions, delivered in a
private setting during outpatient clinic visits or hospitalizations, within a 6-8 weeks
period with board-certified music therapists. The music therapists help patients in
brainstorming and lyric writing, singing and creatively exploring how AYA lyrics and
structure of the selected music fit together, recording their song with a digital
accompaniment track, completing video layout worksheets (determining the contents of
the video), taking and gathering photos or making drawings for the video, and viewing
clip art and pictures on a computer. The music therapist then digitally formats,
compiles, and transfers the AYA-developed music video to a DVD. When completed, the
therapist shares the video with the AYA and offers the option of having a video
"premiere." AYAs who choose a premiere select a date and time for the viewing and
identify individuals they wish to attend (family, friends, healthcare professionals).
After the viewing, AYAs receive a copy of their DVD to keep. Parents' presence and
involvement during all sessions are directed by the AYAs. Parents receive 2 sessions
over 15-60 minutes with a trained study team. During the first session, parents receive
handouts of helpful website resources that have specific information to help parents
support their AYAs. Team members also assure that parents know how to assess the sites.
During the second session, parents receive audio-recorded, telephone-based contact by a
trained nurse who asks them questions focusing on the content available on the provided
website. The trained nurse also answers any questions parents may have.

- Arm II (AYA TMV +P): AYA patients receive intervention as patients in arm I. Parents
receive 3 tailored 60-minute sessions with a trained nurse intervener. Sessions are
recorded to make sure study nurse delivers the sessions according to the study
protocol. Study nurse provides support information to parents using the Robb's
Contextual Support Model, including Managing the Chaos: Self Care as the First Step to
Caring for Your AYA, Relationship Support: How to Listen to and Encourage Your AYA to
Talk; and Strategies for AYA Autonomy Support: Understanding AYA's Ways of Coping.
Session 3 content is also based on the Resilience in Illness model. Sessions are also
tailored to parents' needs, skills practice and/or role playing, and reflection on and
reinforcement of learning. Parents receive written materials on tips and prescribed
skills practice plans.

AYA and parents complete questionnaires including Illness-Related Distress, Defensive
Coping, Spiritual Perspective, Social Integration, Family Environment questionnaires,
Hope-Derived Meaning, Self-Transcendence, Positive Coping, Resilience, Parent Distress, and
Quality of Life at baseline, at 2 weeks after final session, and then at 90 days after final
intervention session. Medical background, intensity of treatment rating scale, and family
demographics are also collected.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Adolescent/young adult (AYA) has initial or relapsed cancer diagnosis and is actively
on treatment and will continue to be on treatment long enough to complete the
intervention and evaluation (4 to 6 weeks)

- AYA meets at least 1 of 3 criteria indicating potentially high palliative care or
end-of-life needs:

- Any high-risk cancer (i.e., metastatic or stage IV)

- Receiving moderate- to high-intensity chemotherapy during 3-5 consecutive days
in an in- or out-patient setting

- A diagnosis with an estimated 5-year event-free survival of < 50%

- No cancers not usually occurring in childhood/adolescent or young adult populations,
such as lung or prostate cancer

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met

PATIENT CHARACTERISTICS:

- AYA is able to participate in sessions as evaluated by the Karnofsky/Lansky score of
50% or greater

- One consistent parent is willing and available to participate in all parent and
evaluation sessions

- AYA is not married and has no children

- No cognitive impairments that would make it difficult for AYA/parents to participate
in the intervention or complete questionnaires (determination in consultation with
attending physician, oncologist, and, for adolescents below age 18, the parents)

- AYA and parent are able to read, understand, and speak English

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label

Outcome Measure:

Illness-related distress and defensive, spiritual perspective, social integration, family environment, positive coping, hope-derived meaning, and resilience and self-transcendence in the AYA TMV+P arm compared to the TMV intervention arm

Safety Issue:

No

Principal Investigator

Joan E. Haase, PhD, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

Unspecified

Study ID:

CDR0000726664

NCT ID:

NCT01556256

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Hematopoietic/Lymphoid Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • psychosocial effects of cancer and its treatment
  • unspecified childhood solid tumor, protocol specific
  • hematopoietic/lymphoid cancer

Name

Location

University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Atlanta, Georgia  30322
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
Riley's Children Cancer Center at Riley Hospital for Children Indianapolis, Indiana  46202-5225